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Pharmacokinetic Study of MIN-101 in Healthy Subjects

Sponsor
Minerva Neurosciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02232529
Collaborator
(none)
32
Enrollment
1
Location
4
Arms
5
Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. The ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Primary Purpose:
Basic Science
Official Title:
A Two-Part Study Designed to Evaluate the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites Following Single and Multiple Dose Modified Release Prototype Formulation Administration in Healthy Cytochrome P450 2D6 Extensive Metabolizer Male and Female Subjects, and to Evaluate the Relationship Between the Pharmacokinetic Profile of MIN-101 and Its Main Metabolites and Cardiovascular Parameters.
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: MIN-101

MIN-101 modified release formulation (MR),single oral dose between 16 and 64 mg

Drug: MIN-101
Experimental: Part 2: MIN-101 low dose

MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7

Drug: MIN-101
Placebo Comparator: Part 2: placebo

placebo MIN-101 daily oral dose from Day 1 to Day 7

Drug: Placebo
Experimental: Part 2: MIN-101 high dose

MIN-101 single daily oral dose, low dose MR formulation, from Day 1 to Day 7

Drug: MIN-101

Outcome Measures

Primary Outcome Measures

  1. Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio [predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose]

  2. Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF) [predose to Day 8]

Secondary Outcome Measures

  1. Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) - [from predose up to 72 h post dosing]

  2. Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state [from predose up to 72 h post dosing]

  3. Part 2 Change from baseline in ECG parameters other than QT/QTc [from predose up to Day 8]

    QTcB, QRS, RR, PR intervals, U waves, T waves morphology

  4. Part 2 Change from baseline in heart rate and blood pressure [from predose up to Day 8]

  5. Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose [from predose up to Day 8]

  6. Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose [from predose up to Day 8]

  7. Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests) [from predose up to Day 8]

Other Outcome Measures

  1. Changes in sleep architecture and sleep continuity [Day 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy males (Part 1 and Part 2) or non-pregnant, non-lactating healthy females (Part 2 only)

  • Body mass index (BMI) of 18.0 to 30.0 kg/m2

  • Must be CYP2D6 Extensive metabolizer

  • Must be willing and able to communicate and participate in the whole study

  • Must provide written informed consent

  • Must agree to use an adequate method of contraception

Key Exclusion Criteria:

  • Subjects who have QTc > 430 in male, > 450 in female confirmed by a repeat ECG

  • Any family history of sudden cardiac death and Torsade de Points

  • No personal or family history of unexplained presyncope, syncope or orthostatic hypotension

  • History of any drug or alcohol abuse in the past 2 years

  • History or evidence of any medically diagnosed clinically significant psychiatric disorders

  • Suicidal tendencies or history of suicidal attempts

  • Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

  • Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening

  • Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)

  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator

  • Positive drugs of abuse test result

  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quotient Clinical Ruddington, Nottingham United Kingdom NG116JS

Sponsors and Collaborators

  • Minerva Neurosciences

Investigators

  • Principal Investigator: Pui Leung, M.D, Quotient Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Minerva Neurosciences
ClinicalTrials.gov Identifier:
NCT02232529
Other Study ID Numbers:
  • MIN-101C02
  • 2014-001613-53
First Posted:
Sep 5, 2014
Last Update Posted:
Feb 24, 2015
Last Verified:
Feb 1, 2015
Keywords provided by Minerva Neurosciences
modified release formulation
pharmacokinetics
Additional relevant MeSH terms:
Schizophrenia

Study Results

No Results Posted as of Feb 24, 2015